N/A
N=120
Differing Completion Rates of DIABETES Education on Patient Reported Outcomes
Diabetes Mellitus, Type 2 · Patient Education as Topic
Bottom Line
View on ClinicalTrials.gov: NCT06419907 ↗Enrolled (actual)
120
Serious AEs
3.5%
Results posted
Sep 2025
Primary outcome: Primary: Change in DSMQ Diabetes Self Management Questionnaire Measuring Diabetes Self Management Skills Pre and Post Intervention — .96; 1.08; .28; -.17 change score (difference in pre-post)
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Type 2 Live Well (structured diabetes self management education programme) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of Liverpool
- Primary completion
- May 2025
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in DSMQ Diabetes Self Management Questionnaire Measuring Diabetes Self Management Skills Pre and Post Intervention |
.96; 1.08; .28; -.17 | — |
| SECONDARY Change in Diabetes Distress (Pre and Post Intervention) Using the Problem Areas in Diabetes (PAID) Tool |
8.14; 7.14; 2.54; -6.5 | — |
| SECONDARY • Mental Health Quality of Life Outcome Measures (Pre and Post Intervention) Using the PROMIS-Global Health V1.2 Scale |
3.0; 1.07; -.88; -.61 | — |
| SECONDARY Physical Health Quality of Life Outcome Measures (Pre and Post Intervention) Using the PROMIS-Global Health V1.2 Scale |
2.27; 2.58; -.67; .48 | — |
Summary
The goal of this clinical feasibility trial is to test the impact of differing completion rates of a face-to-face diabetes self-management education programme on patient-reported outcomes measuring self-care, diabetes distress and quality of life in people with type 2 diabetes. The main question it aims to answer is:
1. What is the impact of differing completion rates of DSME programmes on ability to self-care (primary outcome), diabetes distress and health related quality of life in type 2 diabetes.
Researchers will compare participants across four study groups (Group 1 will receive a full DSME programme, Group 2 will receive 60%, Group 3 will receive 10% and Group 4 will have delayed education) to see if patients who attend minimal aspects (10%) of diabetes self-management education programmes gain clinically significant improvements in ability to self-care compared to those who do not attend and if the nationally accepted 60 % completion rate is as effective as 100% completion.
Participants will:
* complete three validated patient reported outcome measures testing self care activities, diabetes distress and health related quality of life.
* Attend structured diabetes self-management education of differing completion rates dependent on the group they have been allocated to.
* repeat the same three patient reported outcome measures 2-4 months after intervention. For participants in group 4 this will be 3-4 months from baseline.
Eligibility Criteria
Inclusion Criteria
- All patients with a diagnosis of type 2 diabetes aged ≥18 years of age referred to the Diabetes centre who are able to provide informed consent and are responsible for daily management of their diabetes will be screened for entry into the study
Exclusion Criteria
The following patients will be excluded entry into the study:
- Lack capacity to make an informed decision.
- A diagnosis of type 1, type 3c, Maturity-onset diabetes of the young (MODY) or gestational diabetes.
- Received structured education for their diabetes within the last 12 months either online or face to face.
- Require 1: 1 education support e.g., requires interpreter.
- Patients unable to attend for structured classroom education e.g., housebound.
Data sourced from ClinicalTrials.gov (NCT06419907). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.